Workflow
Nuwellis(NUWE)
icon
Search documents
Nuwellis(NUWE) - 2020 Q1 - Quarterly Report
2020-05-14 20:02
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10‑Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2020 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission file number 001-35312 CHF SOLUTIONS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware No. 68-0533453 (State or Other ...
Nuwellis(NUWE) - 2020 Q1 - Earnings Call Transcript
2020-05-12 15:16
CHF Solutions Inc. (CHFS) Q1 2020 Earnings Conference Call May 12, 2020 9:00 AM ET Company Participants John Erb - Chairman, Chief Executive Officer Claudia Drayton - Chief Financial Officer Nestor Jaramillo - Chief Commercial Officer Conference Call Participants Jeffrey Cohen - Ladenburg Thalmann Operator Good morning and welcome to the CHF Solutions earnings conference call for the first quarter ended March 31, 2020. All participants will be in listen-only mode. Should you need assistance, please signal a ...
Nuwellis(NUWE) - 2019 Q4 - Annual Report
2020-03-05 21:59
TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended: December 31, 2019 o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from to Commission file number 001-35312 CHF SOLUTIONS, INC. Eden Prairie, Minnesota 55344 (Address of principal executive offices including zip code) (952) 345-42 ...
Nuwellis(NUWE) - 2019 Q4 - Earnings Call Transcript
2020-03-03 18:56
CHF Solutions, Inc. (CHFS) Q4 2019 Earnings Conference Call March 3, 2020 9:00 AM ET Company Participants Claudia Drayton ??? Chief Financial Officer John Erb ??? Chief Executive Officer and Chairman Nestor Jaramillo ??? Chief Commercial Officer Conference Call Participants Jeffrey Cohen ??? Ladenburg Thalmann Operator Good morning, and welcome to the CHF Solutions Earnings Conference Call for the Fourth Quarter ended December 31, 2019. [Operator Instructions] Participants of this call are advised that the ...
Nuwellis(NUWE) - 2019 Q3 - Quarterly Report
2019-11-08 22:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10‑Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission file number 001-35312 CHF SOLUTIONS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware No. 68-0533453 (State o ...
CHF Solutions, Inc. (CHFS) Sponsored call with MD Panel on Results of Aquadex FlexFlow?? in Pediatric Patients Sept. 25, 2019 (Transcript)
2019-09-26 16:08
CHF Solutions, Inc. (CHFS) Investor Update Conference Call September 25, 2019 1:00 PM ET Company Participants Stuart Goldstein - Cincinnati Children???s Hospital Medical Center David Askenazi - Children???s Hospital of Alabama Shina Menon - Seattle Children???s Hospital Conference Call Participants Jeff Cohen - Ladenburg Thalmann & Co. Operator Good afternoon, and welcome to the CHF Solutions Investor Call. All participants will be in listen-only mode. [Operator Instructions] After today???s presentation, t ...
CHF Solutions (CHFS) Presents At Ladenburg Thalmann Healthcare Conference - Slideshow
2019-09-25 17:24
Financial Highlights - CHF Solutions had approximately 27 million common shares outstanding with a market cap of approximately $6 million as of September 16, 2019 [6] - The company experienced 9 consecutive quarters of double-digit revenue growth [6] - Year 2018 revenue grew 41% compared to 2017 [6] - Q2 2019 revenue was up 53% from Q2 2018 and 38% from Q1 2019 [6] - As of June 30, 2019, CHF Solutions had $74 million in cash on hand and no debt [6] Aquadex FlexFlow System - Aquadex FlexFlow removes 40% more fluid than conventional diuretic drug therapy [24] - Aquadex FlexFlow is associated with a 53% reduction in the risk of heart failure rehospitalization at 90 days compared to diuretics [24] Market Opportunity - The addressable US market segments for Aquadex FlexFlow total over $2 billion annually [80] - The company estimates a $950 million market opportunity in critical care, $900 million in heart failure, and $115 million in pediatrics [32] - There are over 6 million people in the US suffering from heart failure [36]
Nuwellis(NUWE) - 2019 Q2 - Quarterly Report
2019-08-08 21:00
[PART I—FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%E2%80%94FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) For the six months ended June 30, 2019, CHF Solutions reported a net loss of $9.2 million on net sales of $2.9 million, with a 'going concern' uncertainty due to a history of losses and an accumulated deficit of $208.5 million [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2019, total assets increased to $11.4 million from $8.8 million at year-end 2018, primarily due to a rise in cash and cash equivalents, while stockholders' equity grew to $8.4 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2019 | December 31, 2018 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $7,402 | $5,480 | | Total current assets | $10,302 | $8,127 | | **Total Assets** | **$11,428** | **$8,776** | | **Liabilities & Equity** | | | | Total current liabilities | $2,637 | $2,840 | | Total liabilities | $2,994 | $2,840 | | Total stockholders' equity | $8,434 | $5,936 | | **Total Liabilities and Stockholders' Equity** | **$11,428** | **$8,776** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company's net sales grew to $1.7 million for Q2 2019 and $2.9 million for the first six months of 2019, but net loss widened to $4.4 million for the quarter and $9.2 million for the six-month period, driven by increased research and development expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Q2 2019 | Q2 2018 | H1 2019 | H1 2018 | | :--- | :--- | :--- | :--- | :--- | | Net sales | $1,677 | $1,099 | $2,892 | $2,136 | | Loss from operations | $(4,428) | $(4,179) | $(9,153) | $(8,533) | | Net loss | $(4,430) | $(4,181) | $(9,157) | $(8,535) | | Basic and diluted loss per share | $(1.93) | $(13.03) | $(8.82) | $(28.03) | [Condensed Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Stockholders' equity increased from $5.9 million at the end of 2018 to $8.4 million by June 30, 2019, primarily driven by $11.0 million from common and preferred stock issuance, offsetting the net loss - The primary driver for the increase in stockholders' equity during the first half of 2019 was the issuance of common and preferred stock, which provided **$10,959 thousand** in capital, net of costs[19](index=19&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2019, net cash used in operating activities was $8.9 million, offset by $11.0 million from financing activities, resulting in a $1.9 million increase in cash and cash equivalents Cash Flow Summary for the Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2019 | 2018 | | :--- | :--- | :--- | | Net cash used in operating activities | $(8,874) | $(8,478) | | Net cash used in investing activities | $(158) | $(121) | | Net cash provided by financing activities | $10,959 | $0 | | **Net increase (decrease) in cash** | **$1,922** | **$(8,600)** | | **Cash and cash equivalents - end of period** | **$7,402** | **$6,995** | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's focus on the Aquadex FlexFlow® system and disclose a significant 'going concern' risk due to an accumulated deficit of $208.5 million and recurring losses, alongside a March 2019 public offering that raised $12.4 million - The company is a medical device firm focused on the Aquadex FlexFlow® system for aquapheresis therapy, having acquired the business from Baxter in 2016[23](index=23&type=chunk)[24](index=24&type=chunk) - The financial statements were prepared on a going concern basis, but the company's accumulated deficit of **$208.5 million** and history of losses raise substantial doubt about its ability to continue as a going concern for the next twelve months[28](index=28&type=chunk) - In March 2019, the company closed a public offering of common stock, Series G convertible preferred stock, and warrants, raising gross proceeds of **$12.4 million**[49](index=49&type=chunk) - A contingent consideration liability from the Aquadex acquisition, valued at **$126,000** at the end of 2018, was reduced to **$0** as of June 30, 2019, as the likelihood of payment was deemed remote[33](index=33&type=chunk)[58](index=58&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=15&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes the 52.6% year-over-year revenue growth for Q2 2019 to commercialization strategy and in-house manufacturing, while operating expenses increased, and liquidity improved by an $11.0 million capital raise, though 'going concern' risk remains [Results of Operations](index=18&type=section&id=Results%20of%20Operations) For Q2 2019, net sales increased 52.6% to $1.7 million, and gross margin improved due to in-house manufacturing, but operating expenses, particularly R&D, rose significantly due to product enhancement initiatives Net Sales Comparison (in thousands) | Period | 2019 | 2018 | Increase | % Change | | :--- | :--- | :--- | :--- | :--- | | **Three Months Ended June 30** | $1,677 | $1,099 | $578 | 52.6% | | **Six Months Ended June 30** | $2,892 | $2,136 | $756 | 35.4% | - Gross margins improved in 2019 due to the transition to selling internally manufactured inventory, moving away from higher-cost inventory purchased from Baxter under a previous manufacturing agreement[98](index=98&type=chunk)[106](index=106&type=chunk) - Research and development expenses more than doubled in Q2 2019 versus Q2 2018, reflecting investments to improve the Aquadex system, including software updates and catheter enhancements[96](index=96&type=chunk)[101](index=101&type=chunk) [Liquidity and Capital Resources](index=21&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity is primarily sourced from a March 2019 public offering that provided $11.0 million in net proceeds, resulting in $7.4 million in cash and cash equivalents as of June 30, 2019, with management acknowledging potential future financing needs - The company closed a public offering on March 12, 2019, for net proceeds of approximately **$11.0 million**, which is a primary source of its current liquidity[112](index=112&type=chunk) - As of June 30, 2019, the company had cash and cash equivalents of **$7.4 million**, compared to **$5.5 million** at the end of 2018[114](index=114&type=chunk) - Net cash used in operating activities was **$8.9 million** for the first six months of 2019, reflecting the company's net loss for the period[115](index=115&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=23&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company has determined that this section is not applicable, indicating it does not have material exposure to market risks such as interest rate or foreign currency fluctuations - Not applicable[122](index=122&type=chunk) [Item 4. Controls and Procedures](index=23&type=section&id=Item%204.%20Controls%20and%20Procedures) As of June 30, 2019, the company's CEO and CFO concluded that disclosure controls and procedures were effective, with no material changes in internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2019[125](index=125&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[126](index=126&type=chunk) [PART II—OTHER INFORMATION](index=23&type=section&id=PART%20II%E2%80%94OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=23&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently involved in any material legal proceedings - The company is not currently subject to any material legal proceedings[128](index=128&type=chunk) [Item 1A. Risk Factors](index=23&type=section&id=Item%201A.%20Risk%20Factors) The company states there have been no material changes to the risk factors previously disclosed in its Annual Report on Form 10-K for the fiscal year ended December 31, 2018 - There are no material changes to the risk factors discussed in the Annual Report on Form 10-K for the fiscal year ended December 31, 2018[129](index=129&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=24&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) On May 30, 2019, the company granted a market-based warrant to a consultant for investor relations services, allowing the purchase of up to 100,000 shares of common stock at an exercise price of $3.18 per share under a registration exemption - On May 30, 2019, the company granted a market-based warrant to a consultant to acquire up to **100,000 shares** of common stock at an exercise price of **$3.18 per share** in exchange for investor relations services[131](index=131&type=chunk) [Item 5. Other Information](index=24&type=section&id=Item%205.%20Other%20Information) On May 23, 2019, the board of directors amended the New-Hire Equity Incentive Plan, increasing the aggregate number of shares available for issuance from 38,836 to 288,836 to aid in attracting qualified employees - The company amended its New-Hire Equity Incentive Plan to increase the number of shares of common stock available for issuance from **38,836** to **288,836**[134](index=134&type=chunk) [Item 6. Exhibits](index=24&type=section&id=Item%206.%20Exhibits) This section provides an index of all exhibits filed with the Form 10-Q, including corporate governance documents, warrants, certifications by the CEO and CFO, and XBRL data files - The report includes a list of filed exhibits, such as the Common Stock Purchase Warrant dated May 30, 2019, the Sixth Amendment to the New-Hire Equity Incentive Plan, and officer certifications required by the Sarbanes-Oxley Act[135](index=135&type=chunk)[138](index=138&type=chunk)
Nuwellis(NUWE) - 2019 Q2 - Earnings Call Transcript
2019-08-06 18:57
CHF Solutions, Inc. (CHFS) Q2 2019 Earnings Conference Call August 6, 2019 9:00 AM ET Company Participants Scott Gordon - Managing Director of CORE IR John Erb - Chairman and Chief Executive Officer Claudia Drayton - Chief Financial and Officer Nestor Jaramillo - Chief Commercial Officer Conference Call Participants Jeffrey Cohen - Ladenburg Thalmann Kyle Bauser - Dougherty & Company Operator Good morning, and welcome to the CHF Solutions Earnings Conference Call for the second quarter ended June 30, 2019. ...
Nuwellis(NUWE) - 2019 Q1 - Quarterly Report
2019-05-09 21:08
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10‑Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission file number 001-35312 CHF SOLUTIONS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware No. 68-0533453 (State or Ot ...